Soft Tissue Wound HealingNCT05099718
Effect of Hyaluronic Acid on Oral Mucosal Wound Healing - Focus on Pain and Re-epithelisation
A study testing palatal soft tissue harvesting and Hyaluronic acid in people with Soft Tissue Wound Healing, run by Malmö University at 1 site in Sweden.
Trial summary
Establishment of a sufficiently wide and thick keratinized gingival/mucosal tissue cuff around teeth/implants is considered of importance for long-term stability. This can more readily be achieved by means of autogenous soft tissue grafts harvested from the palate than with soft tissue substitutes. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Soft Tissue Wound Healing
- What is being tested?
- palatal soft tissue harvesting and Hyaluronic acid
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteSweden
- Study dates
- 10 Jan 2022to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65 years,
- systemically healthy,
- healthy periodontal conditions at the experimental region or conditions not interfering with proper biopsy harvesting,
- no known sensitivity to HY,
- no uncontrolled diabetes mellitus,
- no radiotherapy or chemotherapy,
Show all 15Show fewer
- no current pregnancy or breastfeeding,
- no hormonal diseases,
- no infectious diseases,
- no autoimmune diseases or under immunotherapy,
- no systemic bone disease,
- no wound healing disorders or acute inflammatory/infectious processes,
- no systemic diseases with implications on mucous membranes (e.g., Morbus Crohn),
- no increased risk of bleeding (i.e., patient with coagulation disorders or under anticoagulant therapy, and
- no heavy smokers (i.e., no regular tobacco consumption > 10 cigarettes/day).
Who cannot join
- not meeting the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Establishment of a sufficiently wide and thick keratinized gingival/mucosal tissue cuff around teeth/implants is considered of importance for long-term stability. This can more readily be achieved by means of autogenous soft tissue grafts harvested from the palate than with soft tissue substitutes. However, this often implies the creation of an open palatal wound involving secondary intention healing. The aim of this randomized controlled, split-mouth, clinical trial is to assess the effect of a hyaluronic acid containing commercial product on wound healing and patient morbidity after palatal soft tissue harvesting. Altogether, 20 volunteers will be recruited. An individualized splint containing 2 symmetrically located contralateral cylindrical openings will be used for standardized soft tissue harvesting (6 mm in Ø, 2 mm in depth). Soft tissue grafts will be harvested randomly from the right or left side and patients will be monitored for 3 weeks followed by a 1-month wash-out period prior to harvesting the second soft tissue graft from the other side. Participants will randomly start treating the palatal wound either with the test product (GUM Aftaclear Gel, Sunstar Suisse SA, Etoy, Switzerland; 0.3%) or saline solution for 7 days to promote the healing process, which will be reversed for the second round. Patient-related outcomes (morbidity, discomfort, taste alteration, pain killer consumption), frequency of bleeding events, defect closure (area, volume), and microbial colonisation will be recorded and analysed for any differences between the control and test product. Further, in 6 additional volunteers, biopsies of the healing wound are collected in a similar fashion as described above, but with the use of a larger stent in order to harvest also pristine surrounding tissues for histological analysis; biopsies are collected up to 14 days of healing.
- Conditions
- Soft Tissue Wound Healing
- Being tested
- palatal soft tissue harvesting, Hyaluronic acid, Saline solution (placebo)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
palatal soft tissue harvestingProcedure or surgery
A 6x2mm palatal soft tissue graft will be harvested.
Hyaluronic acidDevice
application 3-times per day for 7 days
Saline solution (placebo)Other
application 3-times per day for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic acid | Experimental | Application 3-times per day for 7 days. Receives: Procedure: palatal soft tissue harvesting; Device: Hyaluronic acid |
| Saline solution | Placebo comparator | Application 3-times per day for 7 days. Receives: Procedure: palatal soft tissue harvesting; Other: Saline solution (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain / discomfort (burning) perception by means of a 100 mm VAS
0 indicates no pain, 100 indicates maximum pain
Measured: 3 days
pain / discomfort (burning) perception by means of a 100 mm VAS
0 indicates no pain, 100 indicates maximum pain
Measured: 7 days
pain / discomfort (burning) perception by means of a 100 mm VAS
0 indicates no pain, 100 indicates maximum pain
Measured: 14 days
pain / discomfort (burning) perception by means of a 100 mm VAS
0 indicates no pain, 100 indicates maximum pain
Measured: 21 days
Secondary outcomes (35)
pain killer consumption
amount of pills taken
Measured: 3 days
pain killer consumption
amount of pills taken
Measured: 7 days
pain killer consumption
amount of pills taken
Measured: 14 days
pain killer consumption
amount of pills taken
Measured: 21 days
disturbance while eating or drinking by means of a 100 mm VAS
0 indicates no disturbance, 100 indicates maximum disturbance
Measured: 3 days
disturbance while eating or drinking by means of a 100 mm VAS
0 indicates no disturbance, 100 indicates maximum disturbance
Measured: 7 days
disturbance while eating or drinking by means of a 100 mm VAS
0 indicates no disturbance, 100 indicates maximum disturbance
Measured: 14 days
disturbance while eating or drinking by means of a 100 mm VAS
0 indicates no disturbance, 100 indicates maximum disturbance
Measured: 21 days
taste alteration experience by means of a 100 mm VAS
0 indicates no alteration, 100 indicates maximum alteration
Measured: 3 days
taste alteration experience by means of a 100 mm VAS
0 indicates no alteration, 100 indicates maximum alteration
Measured: 7 days
taste alteration experience by means of a 100 mm VAS
0 indicates no alteration, 100 indicates maximum alteration
Measured: 14 days
taste alteration experience by means of a 100 mm VAS
0 indicates no alteration, 100 indicates maximum alteration
Measured: 21 days
frequency of re-bleeding
number of events
Measured: 3 days
frequency of re-bleeding
number of events
Measured: 7 days
frequency of re-bleeding
number of events
Measured: 14 days
frequency of re-bleeding
number of events
Measured: 21 days
re-epithelialised defect area (by means of standardized photographs)
mm2
Measured: 3 days
re-epithelialised defect area (by means of standardized photographs)
mm2
Measured: 7 days
re-epithelialised defect area (by means of standardized photographs)
mm2
Measured: 14 days
re-epithelialised defect area (by means of standardized photographs)
mm2
Measured: 21 days
re-epithelisation by colorimetric digital assessment of the calibrated photographs
colorimetric assessment
Measured: 3 days
re-epithelisation by colorimetric digital assessment of the calibrated photographs
colorimetric assessment
Measured: 7 days
re-epithelisation by colorimetric digital assessment of the calibrated photographs
colorimetric assessment
Measured: 14 days
re-epithelisation by colorimetric digital assessment of the calibrated photographs
colorimetric assessment
Measured: 21 days
changes in total and specific bacterial counts
log values
Measured: 3 days
changes in total and specific bacterial counts
log values
Measured: 7 days
changes in total and specific bacterial counts
log values
Measured: 14 days
defect volume fill by overlay of the intraoral scans
mm3
Measured: 3 days
defect volume fill by overlay of the intraoral scans
mm3
Measured: 7 days
defect volume fill by overlay of the intraoral scans
mm3
Measured: 14 days
defect volume fill by overlay of the intraoral scans
mm3
Measured: 21 days
food restrictions (yes/no)
Measured: 3 days
food restrictions (yes/no)
Measured: 7 days
food restrictions (yes/no)
Measured: 14 days
food restrictions (yes/no)
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start10 Jan 2022
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Soft Tissue Wound HealingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malmö University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Stavropoulos, Malmö University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05099718
- Sponsor's protocol ID
- 2020-01018
- Status last verified
- Jul 2023
- First submitted
- 9 Oct 2021
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dahi M, Amash S, Bertl K, Beck F, Heimel P, Stavropoulos A. Effect of Hyaluronic Acid on Palatal Wound Healing-A Randomized Crossover Clinical Trial. Clin Oral Implants Res. 2026 Jul 16. doi: 10.1111/clr.70159. Online ahead of print.
PubMed 42464383
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hyaluronic Acid on Oral Mucosal Wound Healing - Focus on Pain and Re-epithelisation
- ClinicalTrials.gov ID
- NCT05099718
- Acronym / sponsor ID
- 2020-01018
- Conditions
- Soft Tissue Wound Healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Malmö UniversityUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 29 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Establishment of a sufficiently wide and thick keratinized gingival/mucosal tissue cuff around teeth/implants is considered of importance for long-term stability. This can more readily be achieved by means of autogenous soft tissue grafts harvested from the palate than with soft tissue substitutes. However, this often implies the creation of an open palatal wound involving secondary intention healing. The aim of this randomized controlled, split-mouth, clinical trial is to assess the effect of a hyaluronic acid containing commercial product on wound healing and patient morbidity after palatal soft tissue harvesting. Altogether, 20 volunteers will be recruited. An individualized splint containing 2 symmetrically located contralateral cylindrical openings will be used for standardized soft tissue harvesting (6 mm in Ø, 2 mm in depth). Soft tissue grafts will be harvested randomly from the right or left side and patients will be monitored for 3 weeks followed by a 1-month wash-out period prior to harvesting the second soft tissue graft from the other side. Participants will randomly start treating the palatal wound either with the test product (GUM Aftaclear Gel, Sunstar Suisse SA, Etoy, Switzerland; 0.3%) or saline solution for 7 days to promote the healing process, which will be reversed for the second round. Patient-related outcomes (morbidity, discomfort, taste alteration, pain killer consumption), frequency of bleeding events, defect closure (area, volume), and microbial colonisation will be recorded and analysed for any differences between the control and test product. Further, in 6 additional volunteers, biopsies of the healing wound are collected in a similar fashion as described above, but with the use of a larger stent in order to harvest also pristine surrounding tissues for histological analysis; biopsies are collected up to 14 days of healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic acid | Experimental | Procedure: palatal soft tissue harvesting, Device: Hyaluronic acidApplication 3-times per day for 7 days. |
| Saline solution | Placebo comparator | Procedure: palatal soft tissue harvesting, Other: Saline solution (placebo)Application 3-times per day for 7 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age 18-65 years,
- systemically healthy,
- healthy periodontal conditions at the experimental region or conditions not interfering with proper biopsy harvesting,
- no known sensitivity to HY,
- no uncontrolled diabetes mellitus,
Key exclusion criteria (1 listed)
- not meeting the inclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| palatal soft tissue harvestingA 6x2mm palatal soft tissue graft will be harvested. | Procedure or surgery | Hyaluronic acid, Saline solution |
| Hyaluronic acidapplication 3-times per day for 7 days | Device | Hyaluronic acid |
| Saline solution (placebo)application 3-times per day for 7 days | Other | Saline solution |
Primary outcome
pain / discomfort (burning) perception by means of a 100 mm VAS
Time frame: 3 days
0 indicates no pain, 100 indicates maximum pain
pain / discomfort (burning) perception by means of a 100 mm VAS
Time frame: 7 days
0 indicates no pain, 100 indicates maximum pain
pain / discomfort (burning) perception by means of a 100 mm VAS
Time frame: 14 days
0 indicates no pain, 100 indicates maximum pain
pain / discomfort (burning) perception by means of a 100 mm VAS
Time frame: 21 days
0 indicates no pain, 100 indicates maximum pain
35 secondary outcomes
pain killer consumption
Time frame: 3 days
pain killer consumption
Time frame: 7 days
pain killer consumption
Time frame: 14 days
pain killer consumption
Time frame: 21 days
disturbance while eating or drinking by means of a 100 mm VAS
Time frame: 3 days
disturbance while eating or drinking by means of a 100 mm VAS
Time frame: 7 days
disturbance while eating or drinking by means of a 100 mm VAS
Time frame: 14 days
disturbance while eating or drinking by means of a 100 mm VAS
Time frame: 21 days
taste alteration experience by means of a 100 mm VAS
Time frame: 3 days
taste alteration experience by means of a 100 mm VAS
Time frame: 7 days
taste alteration experience by means of a 100 mm VAS
Time frame: 14 days
taste alteration experience by means of a 100 mm VAS
Time frame: 21 days
frequency of re-bleeding
Time frame: 3 days
frequency of re-bleeding
Time frame: 7 days
frequency of re-bleeding
Time frame: 14 days
frequency of re-bleeding
Time frame: 21 days
re-epithelialised defect area (by means of standardized photographs)
Time frame: 3 days
re-epithelialised defect area (by means of standardized photographs)
Time frame: 7 days
re-epithelialised defect area (by means of standardized photographs)
Time frame: 14 days
re-epithelialised defect area (by means of standardized photographs)
Time frame: 21 days
re-epithelisation by colorimetric digital assessment of the calibrated photographs
Time frame: 3 days
re-epithelisation by colorimetric digital assessment of the calibrated photographs
Time frame: 7 days
re-epithelisation by colorimetric digital assessment of the calibrated photographs
Time frame: 14 days
re-epithelisation by colorimetric digital assessment of the calibrated photographs
Time frame: 21 days
changes in total and specific bacterial counts
Time frame: 3 days
changes in total and specific bacterial counts
Time frame: 7 days
changes in total and specific bacterial counts
Time frame: 14 days
defect volume fill by overlay of the intraoral scans
Time frame: 3 days
defect volume fill by overlay of the intraoral scans
Time frame: 7 days
defect volume fill by overlay of the intraoral scans
Time frame: 14 days
defect volume fill by overlay of the intraoral scans
Time frame: 21 days
food restrictions (yes/no)
Time frame: 3 days
food restrictions (yes/no)
Time frame: 7 days
food restrictions (yes/no)
Time frame: 14 days
food restrictions (yes/no)
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
- Derived from this study: PubMed 42464383Dahi M, Amash S, Bertl K, Beck F, Heimel P, Stavropoulos A. Effect of Hyaluronic Acid on Palatal Wound Healing-A Randomized Crossover Clinical Trial. Clin Oral Implants Res. 2026 Jul 16. doi: 10.1111/clr.70159. Online ahead of print.
Related trials for Soft Tissue Wound Healing
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 2/3
Lactoferrin Nanohydrogel for Soft And Hard Tissue Healing and Implant Stability in Immediate Implant Placement
Dental Implant, Wound Healing
Not yet recruiting
Antibacterial Effect and Soft Tissue Healing of Chlorhexidine-Coated Polyglactin 910 Sutures After Impacted Lower Third Molar Surgery
Impacted Third Molar Tooth, Surgical Wound Healing
Active, not recruitingPhase 2
Study of DNA Damage, Angiogenesis, and PD-L1 Inhibitors in Advanced Solid Tumors
Mismatch Repair Proficient Colorectal Cancer, Pancreatic Adenocarcinoma
Not yet recruitingObservational study
Urinary Bladder Matrix (UBM) Registry
Tissue Repair, Soft Tissue Reconstruction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing palatal soft tissue harvesting and Hyaluronic acid in people with Soft Tissue Wound Healing, run by Malmö University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain / discomfort (burning) perception by means of a 100 mm VAS (time frame: 3 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05099718, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2023.